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Quality Engineer - Medical Devices & CAPA Lead
Boston Scientific Gruppe
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batu kawan, Malaysia
Location
batu kawan
Posted
June 12, 2026
Commute
Local Area
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Job Description
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- Develop and maintain effective quality systems, process controls, and methodologies to ensure compliance with regulatory, customer, and internal requirements
- Support manufacturing quality activities, including product qualification, process validation, and ongoing improvement initiatives
- Identify, analyze, and resolve product and process quality issues using structured problem-solving and data analysis
- Lead or support investigations on nonconforming products, customer complaints, and manufacturing defects; implement corrective and preventive actions (CAPA)
- Review and develop validation and test protocols; execute qualification and validation activities with proper documentation
- Participate in new product introductions, technology transfers, and evaluation of new equipment and processes
- Ensure compliance with Quality Management Systems (QMS) and applicable re...